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Personal Health Record · Not a Medical Device

Medical Disclaimer

Version
v2.3
Effective
4 November 2026
Binding language
English

1Summary

Medical information is powerful and easy to misread. VitaMedas exists so that you can keep your own records under your own control — and share them, on your terms, with the people qualified to interpret them. We have designed the product, and these Terms, to make absolutely clear what VitaMedas does and does not do. This page sets out the boundary in detail.

2What VitaMedas is

VitaMedas is a Personal Health Record (PHR). In practical terms:

  • it lets you upload and store medical records (DICOM imaging, PDFs, photos, lab reports, ECGs, audio recordings, doctor's notes, video clips, mesh files, and similar);
  • it lets you view those records in your browser using high-quality viewers (DICOM 2D / MPR / 3D / MIP, PDF, image, ECG, video, whole-slide imaging, NIfTI, STL/OBJ/PLY 3D scans);
  • it lets you organise, annotate, search, and compare records;
  • it lets you share specific records with a specific doctor or hospital, on your terms, for a window you choose;
  • it lets you ask an AI model (Google Gemini, currently) to produce a descriptive summary of a record or to translate it — see section 4;
  • in the Vita app, it lets you ask health questions and get general information in plain language, including about a lab report you share — see section 4;
  • it keeps the records in your vault end-to-end encrypted, so VitaMedas itself cannot read them. A record you choose to send for an AI description is decrypted on your device and sent for that one request only.

3What VitaMedas is not

VitaMedas is explicitly not, and you should not treat it as:

  • A medical device or medical-device software (MDSW). We do not claim, intend or design VitaMedas to perform any medical purpose within the meaning of Regulation (EU) 2017/745 (MDR), the UK Medical Devices Regulations 2002, or the Turkish Tıbbi Cihaz Yönetmeliği (SGM Yön. 02.06.2021). VitaMedas does not diagnose, prevent, predict, prognose, treat or alleviate disease, and it does not monitor anyone’s condition: it does not watch for a change or send an alert about one. Showing you your own past records and values, with their dates and printed ranges, is a record you can read. When you give Vita a new report, it can say whether a value went up, went down or stayed about the same, beside the printed range. That is your own record shown back to you, only when you bring it. That display gives no verdict, no prediction, no alert on a threshold and no treatment suggestion. An answer can still tell you to seek care, as any answer can.
  • A diagnostic tool. The viewer renders pixels and metadata. The interpretation of those pixels is a clinical activity reserved to qualified clinicians acting in the context of a doctor–patient relationship.
  • A clinical decision-support system (CDSS). VitaMedas does not generate, propose or rank clinical recommendations. The prompt in the Vita app about when to see someone (section 4) is general safety information, not a clinical recommendation.
  • A telemedicine or e-consultation platform. Sharing a record with a doctor through VitaMedas is document transfer, not consultation. The clinical relationship — if any — is between you and the doctor; VitaMedas is not a party to it.
  • A laboratory or radiology information system. We do not produce primary clinical records; we store the records others produce.
  • A 24/7 alerting or monitoring service. The Service does not watch your health and does not alert anyone to a change in it. If a new detail or a new result reaches Vita, it can offer to read a report again or tell you that something is waiting. That is a convenience you choose. It is not monitoring.

We reserve the right to disable any feature whose use a regulator considers to cross into medical-device territory, without notice, to preserve the PHR positioning of the Service.

4AI features — information, not medical advice

The Service uses a third-party large language model (currently Google Gemini) in two places, and they work differently.

4.1An AI description of a record

The Service includes an optional “AI description” feature that uses that model to produce a written description or translation of a record you choose. This feature is bound by strict rules in our prompting and presentation:

  1. The AI is instructed to describe what is visible (e.g. “there is increased opacity in the right lower lobe of the lung field”) and never to diagnose (“you have pneumonia”).
  2. The AI is instructed to refuse to recommend treatment, advise on severity or urgency, or imply that its output is medical advice. Where the safety guardrails on the model intercept advice-like output, we display the safe fallback.
  3. The output is preceded and followed by a disclaimer that the content is AI-generated, descriptive, and not medical advice.
  4. The AI feature is opt-in per request. We do not background-process your vault.
  5. Models make mistakes. We do not warrant the accuracy of any AI output. You should not rely on it for any clinical purpose.

4.2The Vita assistant

The Vita assistant answers the health questions you ask. It explains lab results and documents you give it in plain language. It also says how soon something is worth seeing a clinician about, and whom to see, including “now” when something sounds urgent. It closes by pointing you to a doctor or pharmacist.

  • It gives general health information. It does not diagnose, it does not tell you that you have a disease, and it does not prescribe or give you a dose.
  • A line about how soon to see someone is a general safety prompt, written by an AI model from what it was told. It is not a triage decision or a clinical assessment, and it can be wrong in either direction.
  • A picture of a scan is described, not read. Vita names no disease and estimates no severity, and it sends you to the clinician who reads such images.
  • A message that suggests an emergency or self-harm gets a fixed message instead of an answer: see the Crisis Protocol.
  • Models make mistakes. We do not warrant the accuracy of any answer.

By using the AI features you acknowledge these limitations and accept that the output is for your information only.

5No reliance for clinical decisions

Vita can explain a result and say how soon it is worth seeing someone. The decision stays with you and your clinician. You must not use the Service to:

  • replace a clinician’s judgement on whether you need medical attention or how urgently, or decide not to seek care because Vita did not tell you to;
  • self-diagnose, self-medicate or postpone seeking advice from a qualified clinician;
  • make a clinical decision from an imaging study, lab result or ECG without a clinician;
  • communicate clinical advice to another person.

Always seek the advice of a qualified physician or other health-care professional with any question you may have regarding a medical condition. Never disregard professional medical advice or delay seeking it because of something you have read or seen on VitaMedas.

6Emergencies

What Vita does when a message suggests an emergency or self-harm is in the Crisis Protocol.

7Use by clinicians and hospitals

A doctor or hospital who receives a share through VitaMedas may rely on it as one source of information in their normal clinical workflow. The clinical responsibility for any decision taken on the basis of that information rests with the clinician, their employing institution, and the applicable clinical governance framework.

VitaMedas does not:

  • guarantee that a record uploaded by a patient is complete, current, authentic or unaltered;
  • warrant the diagnostic quality of a viewer rendering relative to a calibrated diagnostic workstation;
  • assume any clinical, malpractice or vicarious liability for the acts or omissions of a clinician or institution that uses the Service.

Clinicians and hospitals using the Service in their practice are subject to our Data Processing Agreement and remain the data controller of patient records.

8Regulatory status

  • European Union — VitaMedas is positioned as a non-medical-device PHR. We have not registered it as a medical device under MDR 2017/745. If we ever add features that bring the Service within the MDR definition of a medical device, we will undertake the relevant conformity-assessment procedure before activating those features for users in the EU.
  • United Kingdom — VitaMedas is not registered with the MHRA as a medical device. Same commitment as above: should we ever cross the line, we will obtain UKCA certification before activation.
  • Türkiye — VitaMedas is not registered with TİTCK as a medical device. The Service is a kişisel sağlık kaydı (PHR) under the Kişisel Sağlık Verileri Yönetmeliği (2019). We comply with KVKK in respect of personal-data processing.
  • United States, Canada, Australia, others — see country-specific notices when launched. Where local law requires registration of a PHR or imposes data-residency rules, we will implement them or refrain from offering the Service.

If you are a regulator with a question about our positioning, please write to legal@vitamedas.com and we will respond promptly.

9Limitations and assumptions of risk

You acknowledge and accept that:

  • the Service is provided “as is” and “as available” under the warranty disclaimer at section 12 of the Terms of Service;
  • viewer renderings, AI answers, summaries and translations may contain errors, artefacts or omissions and must not be relied on for any clinical purpose;
  • if you forget your vault passphrase, your records are unrecoverable;
  • our liability is limited as set out in section 13 of the Terms of Service.

10Your responsibility

By using the Service you agree that you, and not VitaMedas, are responsible for any clinical decision or omission made by you or by a third party on the basis of information stored in or shown by the Service. You agree to indemnify us against any claim arising from such decisions on the terms set out in section 14 of the Terms of Service.

11Contact

Questions about regulatory status, AI features or this disclaimer: legal@vitamedas.com.

Statutory references

  • MDR · Regulation (EU) 2017/745 on medical devices
  • MDCG · MDCG 2019-11 — Qualification and classification of software
  • TR MDR · Tıbbi Cihaz Yönetmeliği, 02.06.2021
  • TR PHR Reg. · Kişisel Sağlık Verileri Hakkında Yönetmelik, 21.06.2019
  • UK MDR · UK Medical Devices Regulations 2002 (as amended)
  • FDA SaMD · 21 CFR 820 — Software as a Medical Device (US, reference only)

Questions, requests, or complaints?

VitaMedas is operated by VitaMedas, Inc. (commercial name VitaMedas), 2261 Market Street STE 69554, San Francisco, CA 94114, United States.

Document last updated 4 November 2026 · Version v2.3 · Previous versions available on request.